FDA.reportPublic FDA data

hema-screen

Primary DI
20722355001122
Brand
hema-screen
Company
Immunostics Company, Inc
Model
HSDV-8
Device description
Fecal Occult Blood Reagent, Guaiac
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHEREAGENT, OCCULT BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20722355001122PackageGS110In Commercial Distribution
10722355001125PrimaryGS10
80722355001124Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2072235500112220722355001122
1072235500112510722355001125
8072235500112480722355001124

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(732)918-0770technical@immunostics.com

Regulatory Flags#

DUNS number
119214195
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722355002894hema-screen SPECIFIC GOLDHSGD-25HSGD-252025-04-16
10722355002900hema-screen SPECIFIC GOLDHSGDCAS-25HSGDCAS-252025-04-16
10722355003068hema-screen SPECIFIC GOLDHSGDENV-20HSGDENV-202025-04-16
10722355001002hema-screenHS-502016-09-23
10722355001019hema-screenHS-1002016-09-23
10722355001026hema-screenHS-10002016-09-23
10722355001033hema-screenHS-342016-09-23
10722355001040hema-screenHSPP-502016-09-23
10722355001057hema-screen STATHSTAT-502016-09-23
10722355001071hema-screen SPECIFICHSSP-252016-09-21
10722355001095hema-screen SPECIFICHSSPCAS-252016-09-21
10722355001101hema-screen SPECIFICHSSPENV-202016-09-21
10722355001125hema-screenHSDV-82016-09-23
10722355001255Detector MonoIDM-252016-09-22
10722355001453Detector PersonalIDP-32016-09-20
10722355001668Detector Strep AIST-501-OBC33IDSTREP-252016-09-21
10722355002016Detector H. pyloriIHP-102016-09-22
10722355002023Detector H. pyloriIHP-302016-09-22
10722355002146hema-screen Triple 335HSTR-335CS2016-09-23
10722355002221Detector UA 10IDU-102016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816862028324WELLlife™ WONDFO USA CO., LTD.KHE2026-05-15
00816917027821OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2026-03-25
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestTECO DIAGNOSTICSKHE2026-01-30
10722066011338Rapid ResponseBTNX IncKHE2026-01-02
20722066011335Rapid ResponseBTNX IncKHE2026-01-02
00816917027173OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2025-05-02
10722355002894hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355002900hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355003068hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
00850036464662Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
20850036464666Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
00816862025972WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
00816917026374OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-06-28
00850054026590QMedix™Diagnostic Automation, Inc.KHE2024-05-10
10023513132157Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-04-26
00816917026244OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-02-19
10023513132140Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-01-23
00816917026121OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-10-26
00810143620023GenaCheck Rapid Self-Test Kit for FOBGenabio Diagnostics Inc.KHE2023-10-06
10722066007102Rapid ResponseBTNX IncKHE2023-06-15
00722066004302Rapid ResponseBTNX IncKHE2023-06-15
00816917026015OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-03-14
00816917025728OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-18
00816917025704OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-08
00816917025681OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-03-28
00816917025582OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-12-20
30080196165142MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
10080196165148MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
00816917025506OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-10-14